Frontlight ResearchEarly access
WithdrawnNo phase
Knee Osteoarthritis Outcome Measures in Arthritic Patients With Osteoporosis
Key facts
- Who runs it
- Edward Fox
- Where
- Hershey, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 1 Jan 2020
- Ended
- 31 Dec 2024
- Type of study
- Observational, 2 groups
- Record updated
- 24 October 2019
- Why it stopped
- never started
Who can take part
- Age
- 40 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Age: 40-80 years (inclusive)
- Gender: male or female (non-pregnant)
- Fluent in written and spoken English
- Patients capable of giving informed consent
- Primary diagnosis of osteoporosis that will be treated with either Forteo® to induce bone anabolism or Prolia® by the study investigator as part of patient's standard of care treatment
- Symptomatic, medial compartment knee OA with a Kellgren-Lawrence (K-L) score between II-III (documented in the medical record by previously collected knee series radiography). Radiographs to be performed within past two years
Who cannot take part
- Depression (currently taking home medication)
- Use of immunosuppressants, chemotherapy, or radiotherapy
- Cognitive impairment
- History of hyperparathyroidism, hypercalcemia, current/recent renal stones, or malignancy
- History of inflammatory disease (colitis, rheumatoid arthritis, psoriasis, lupus, scleroderma, spondylitis)
- Age < 40 or >80 years
- Pregnancy
- Non-English speaking persons
- BMI, angular deformity and K-L score of the contralateral knee (if the OA is bilateral) will be noted as covariates
Where in United States
- Penn State Milton S. Hershey Medical CenterHershey, United States
About the trial
What the trial wants to find out
The purpose of this study is to generate proof of concept human data by evaluating osteoarthritis outcome measures in arthritic patients that are prescribed Forteo® as the standard of care to treat their primary diagnosis of osteoporosis.
The 2 groups in the trial
- Forteo
teriparatide 20-microgram once daily available in a 2.4-mL delivery device for subcutaneous injection by the patient
- Prolia
denosumab 60 mg administered as a single subcutaneous injection every 6 months by the health care provider
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pilot Study to Evaluate Knee Osteoarthritis Outcome Measures in Arthritic Patients Prescribed Forteo or Prolia for Osteoporosis
- Record updated
- 24 October 2019